Pharmaceutical Consulting
Pharmaceutical Consulting
Regulatory Affairs
Quality Assurance
Entity Licensing
Pharmacovigilance
Marketing and Advertising
Support Services

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Regulatory Affairs
Regulatory Affairs

Pharmadvance ensures the completion of the activities inherent to the placement and maintenance of medicinal products, medical devices, cosmetics and food supplements on the market.

Entity Licensing
Entity Licensing

Pharmadvance supports companies seeking to license the manufacturing or wholesale distribution activity of medicinal products for human use and medical devices, simultaneously ensuring the compliance with the requirements of the applicable Good Practices.

Pharmacovigilance
Pharmacovigilance Services

Pharmacovigilance System Master File (PSMF)
Operating procedures and work instructions
Maintenance of the quality management system that supports PhV activities
Local and international literature monitoring
ICSR (Individual Case Study Report) management
PSUR (Periodic safety update reports) and RMP (Risk Management Plan) elaboration
Signal Management
PhV training
Local QPPV
Audit and Inspection Support

QA
Quality Assurance

Focusing on the continuous improvement of processes, Pharmadvance offers support on implementation and maintenance of Quality Management Systems adjusted to your needs, always in compliance with the applicable norms and guidelines.

Marketing and Advertising
Marketing and Advertising

Pharmadvance offers a set of services targeted to Marketing and Advertising of medicines and healthcare products, developing customized strategies that enable customers to achieve a strong and solid presence in the market given the increasing competitiveness of the sector.

Support Services
Support Services

Training
Technical and scientific translations
Legal support

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Regulatory Affairs

Lifecycle monitoring of:

  • Medicinal Products for Human Use
  • Medicinal Products for Veterinary Use
  • Medical Devices
  • Cosmetics
  • Food Supplements

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Quality Assurance

  • Implementation and Maintenance of Quality Management Systems
  • Internal Audits of Quality Management Systems
  • Mock Audits
  • Change Controls, Deviation Management, CAPA, Risk Management
 

Entity Licensing

  • Manufacturers of Medicinal Products for Human and Veterinary Use
  • Manufacturers of Medical Devices
  • Wholesale Distributors of Medicinal Products for Human and Veterinary Use
  • Wholesale Distributors of Medical Devices
  • Retail Establishments of Medicinal Products for Veterinary Use
  • Intermediation of Medicinal Products for Human Use
  • Non-Prescription (OTC) Medicines Retailers

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Marketing and Advertising

  • Regulatory support
  • Elaboration, review and notification of advertising materials
  • Product Marketing
  • Market research
  • Brands representation

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Pharmacovigilance

  • Pharmacovigilance System Master File (PSMF)
  • Operating procedures and work instructions
  • Maintenance of the quality management system that supports PhV activities
  • Local and International Literature Monitoring
  • ICSR (Individual Case Study Report) management
  • PSUR (Periodic Safety Update Reports) and RMP (Risk Management Plan) elaboration
  • Signal Management
  • PhV training
  • Local QPPV
  • Audit and Inspection Support
 

Support Services

  • Training
  • Technical and scientific translations
  • Legal support

More info: Click here

 

 

Partners

 

About

Pharmadvance focuses on providing pharmaceutical consulting services with expertise in Regulatory Affairs, Quality Assurance, Entity Licensing and Marketing and Advertising of medicines and healthcare products.

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